SCANLAN® A/V Punch

FDA UDI

Class I (US FDA UDI)

by Scanlan International Inc

Identity

Trade Name: SCANLAN® A/V Punch FDA UDI
Generic Name: Aorta punch, single-use FDA UDI
Device Name: Single-Use A/V Punch,Bulk Non-Sterile, 5.5 mm, 5-3/4"/14.5 cm long (5/pkg) FDA UDI
Model / Reference: 1001-606B FDA UDI
Description: Single-Use A/V Punch,Bulk Non-Sterile, 5.5 mm, 5-3/4"/14.5 cm long (5/pkg) FDA UDI

Identifiers

Catalog Number: 1001-606B FDA UDI
Primary DI / UDI-DI: 00846159025811 FDA UDI
FDA Product Code: KDC FDA UDI
GMDN Term: Aorta punch, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Radiation Sterilization FDA UDI

Category: Aorta punch, single-use

SCANLAN® A/V Punch by Scanlan International Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Aorta punch, single-use.

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Aorta Punch 14 cm - 5 1/2" Ø 4.0 mm Stainless Steel — SURTEX INSTRUMENTS LTD · Class I
A&E Medical / Rotating Surgical Punches — A & E MEDICAL CORPORATION · Class I
Aortic Punch — MEDTRONIC, INC. · Class I
CleanCut RCL45 Bulk Nonsterile — QUEST MEDICAL INC · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Scanlan International Inc

Sources (1)

FDA UDI bee56f4a-6d03-41b2-bc0b-049007b31eca 35 fields · synced Jun 6, 2026